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Conference SecretariatConference Series LLC 2360 Corporate Circle, Suite 400 Henderson, NV 89074-7722, USA

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Tentative Program

http://clinicaltrials.pharmaceuticalconferences.com

conferenceseries.com

Theme: “Safer Drug Innovations & Critical Considerations in Clinical Trials”

March 28-29, 2018 Orlando, USA

11th Annual Congress on

Pharmacovigilance and Clinical Trials

**For Available Speaker Slots**[email protected]


09:45‐10:15

Plenary Session 1| Tracks 1 & 2Pharmacovigilance and Drug Safety|Pre‐Clinical and

Clinical Trials

Plenary Session 2 | Tracks 3 & 4 | Track 5acodynamics and Pharmacokinetics|Clinical Data Manag

Adverse Event Reporting

Plenary Session 3 | Track 6 &7Clinical and Medical Case Reports| Pharmacovigilance

Data Base ManagementPanel Discussions | Extended Networking

Evening Sessions 15.45-18.00

Netwroking Lunch 12.40‐13.30

Keynote Talk 3

Keynote Talk 4

Pre‐Lunch Session 11.00-12.40

13.30-15.30

Coffee/Tea Break 10.45‐11.00


Post Lunch Sessions

SCIENTIFIC PROGRAMDAY 1

10:15‐10:45

Keynote Talk 108:45‐09:15

Keynote Talk 2

Keynote Session

09:15‐09:45








Keynote Session09:00 ‐ 09:45

09:45 ‐ 10:15

10:15 ‐ 10:45

Pre‐Lunch Session 11.00-12.40 Plenary Session 4| Track 8Clinical Trial Regulatory Challenges

Post Lunch Sessions 13.30-15.30 Plenary Session 5 | Tracks 9 &10Data Quality Management and Analysis | Design of Clinical Studies and Trials

Evening Sessions 15.45-18.00 Plenary Session 3 | Track 11Clinical Research

Panel Discussions | Extended Networking


Closing and Award Ceremony


Netwroking Lunch 12.40‐13.30

Keynote Talk 6

Keynote Talk 7

Keynote Talk 5

DAY 2

Glimpses of Pharmacovigilance and Clinical Trials


TOURIST DESTINATIONS IN ORLANDO

Blizzard Beach Pool Discovery Cove

Disney Hollywood Studios

Harry P Leu Gardens

Island of Adventure

Magic Kingdom

Disneys Animal Kingdom

Hollywood Drive In Glof

Lake Eola Park

Morocco Pavilion

Contact usAmerica: Conference Series LLC

Allergy-Clinical Immunology 2017One Commerce Center-1201

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Phone: +1-888-843-8169, Fax: +1-650-618-1417, Toll free: +1-800-216-6499

Email: [email protected]

Contact us Asia-Pacific: Conference Series

Allergy-Clinical Immunology 2017Divyasree Building, Raidurg

6th Floor, North Block Hyderabad 500032, INDIA

Tel: 040-33432334Email: [email protected]

Contact us UK: Conference Series Limited

Allergy-Clinical Immunology 2017Heathrow Stockley Park Lakeside House

1 Furzeground WayHeathrow, UB11 1BD, UK

Tel: +1-800-216-6499Email: [email protected]

Conference VenueOrlando, Florida, USA

September 2016 Volume 4, Issue 5ISSN: 2329-6887

Journal of PharmacovigilanceOpen Access

September 28-30, 2016Toronto, Canada

Proceedings of

conferenceseries.com702nd Conference

Email: [email protected]

Conference Series Ltd2360 Corporate Circle., Suite 400 HendersonNV 89074-7722, USAPh: +1-702-508-5200 Ext: 8074, Toll free: +1-800-216-6499

Conference Series LtdHeathrow Stockley Park Lakeside House1 Furzeground Way, Heathrow, UB11 1BD, UK, Tel: +1-800-216-6499

Hosting Organizations

6th Pharmacovigilance Congress

08:30-09:15 Registrations

Meighen Room

Day 1 September 28, 2016

Lunch Break: 13:00-14:00 @ Cabinet Room

Sessions: Drug Safety | Case Study | Pharmacy Practice and its Challenges

Session Chair: Sutapa Bandyopadhyay NeogiSession Introduction

14:00-14:30Title: Tablet splitting of psychotropic drugs for patients with dementia: A pharmacoepidemilogic study in a Brazilian samplePatricia Medeiros-Souz, Universidade de Brasília, Brazil

14:30-15:00Title: Nucleoside drug safety improvement via pronucleotide approachesZhihong Xu, South College, USA

15:00-15:30Title: Blockade of the NMDA receptor in developing cortex induces autophagy-mediated death of migrating cortical GABAergic interneurons: an ex in vivo and in vivo study in GAD67-GFP miceBruno J Gonzalez, Normandy University/Inserm NeoVasc, Rouen, France

15:30-16:00Title: Pattern of hospital-acquired pneumonia in intensive care unit of Suez Canal University hospitalNermine El maraghy, Suez Canal University, Egypt

Networking & Refreshments Break: 16:00-16:20 @ Foyer

16:20-16:50Title: Pharmacovigilance as a tool for conducting clinical trials with plant-based medicinesLiaquat Ali, Bangladesh University of Health Sciences, Bangladesh

Panel Discussion

Day 2 September 29, 2016Algonquin Room AKeynote Forum

09:45-10:45 Title: Can Pharmacist ensure drug safety in the healthcare system or are there barriers Panjasaram Naidoo, University of KwaZulu Natal, South Africa

Networking & Refreshments Break: 10:45-11:00 @ FoyerSessions: Pharmacy Practice & its Challenges

Session Introduction

11:00-11:30Title: Indigenous medicine use for sex selection during pregnancy and risk of congenital malformations and stillbirthsSutapa Bandyopadhyay Neogi, Indian Institute of Public Health-Delhi (IIPH-D), India

Opening Ceremony09:15-09:35conferenceseries.com

Keynote ForumKeynote Forum

09:35-09:40 Introduction09:40-10:40 Title: Pharmacovigilance and compliance of drugs labeling information with the 2015 FDA lactation guidelines Gamal Hussein, South College School of Pharmacy, USA

Group Photo: 10:40-10:45Networking & Refreshments Break 10:45-11:00 @ Foyer

11:00-12:00 Title: Efficacy, safety and pharmacokinetic profiles of a plasma-derived VWF/ FVIII concentrate (Voncento) in subjects with haemophilia A (SWIFT-HA study) Aleksander Skotnicki, Szpital Uniwersytecki w Krakowie, Poland12:00-13:00 Title: The use of laser therapy in dermatology(Benign pigmented lesions) Ossama Roshdy, Alexandria University, Egypt

11:30-12:00Title: The synthesis of potentially bioactive new compounds in the field of 3,4-Disubstituited -5-Mercapto -1, 2,4-Tiazoles YMelanya A. Samvelyan, Yerevan State University, Armenia

Young Research ForumSessions: Drug safety | Pharmacy Practice & Challenges | Preclinical and Clinical Trials on various disorders

12:00-12:15Title: Survey on counterfeiting of Amoxicillin and Amoxicillin + Clavulanic acid marketed in lubumbashiPierrot Mwamba T, University of Lubumbashi, Congo

12:15-12:45Title: Over-the-counter (OTC) products withdrawn from the united states due to the inclusion of undeclared prescription ingredients in the past 15 yearsLavesh Patel, South College School of Pharmacy, USA & Maame Twum, South College School of Pharmacy, USA

12:45-13:00Title: Targeting population for AST: previous allergy history and Cephalosporin skin test positivityDong-Yoon Kang, Seoul National University Hospital, Korea

Lunch Break: 13:00-14:00 @ Cabinet RoomPoster Presentation Session @ 14:00 -15:45

PVC01 Title: Derivatives of 1,2,4-Triazoles: Synthesis and study of biological activityArmen S Galstyan, Yerevan State University, Armenia

PVC02 Title: New syntheses in the field of τ-Lactones and biological studies of the obtained compoundsTariel V Ghochikyan, Yerevan State University, Armenia

PVC03 Title: Radical scavenging activity and phytochemical constituent of Tulipa Systola StapfMohammed Farhad Ibrahim, University of Salahaddin, Iraq

PVC04Title: Prenatal exposure to alcohol impairs the long term integration of GABA interneurons and the proteolytic endothelial activity in mouse neonatesCecile Leger, Normady University, France

PVC05Title: Prospective observational study for Oxaliplatin induced hypersensitivity: experience in a single institute during 2 yearsKyoung-hee Sohn, Seoul National University College of Medicine, South korea

PVC06Title: Pharmacovigilance and compliance of drugs labeling information with the 2015 FDA lactation guidelinesFaten Sabbagh, South College School of Pharmacy, USA

PVC07Title: Audit of the introduction of MYMATHLAB for first year and second year mpharm studentsMajdi Garsan Algarsan, University of Hertfordshire, UK

PVC08Title: The distribution of CYP2B6 variants in Roma from CroatiaBranka Janicijevic, Institute for Anthropological Research, Croatia

PVC09Title: Epidemiologic study based on adverse drug events in patients visiting emergency department: a retrospective observational study in three university hospitalMin-Gyu Kang, Chungbuk National University, Korea

PVC10Title: Bronchoprovocation study of Albuterol inhalation on asthma patients: A Pharmacodynamic Bioequivalence Study Nailesh Patel, Ganpat University, India

Networking & Refreshments Break: 15:45-16:00 @ FoyerPanel DiscussionAward Ceremony

Day 3 September 30, 2016Algonquin Room A

B2B Meetings @ 10:00-10:45Networking & Refreshments Break: 10:45-11:00 @ Foyer

Academic Research Meetings @ 11:00-13:00Lunch Break: 13:00-14:00 @ Cabinet Room

Panel DiscussionAward Ceremony

Thanks Giving Ceremony

08:30-09:30 Registrations

Opening Ceremony09:30-09:55

Gates Suite

Day 1 August 10, 2015

Track 1: Concept of Pharmacovigilance and its Significance and Scope Track 7: Pharmacovigilance and Risk Management Track 8: Clinical Research and Statistics Session Chair: Kieran O’Donnell, TMC Pharma Services, UKSession Co-Chair: Peter Lannon, Lanpharm Consulting T/A Lanpharm Services, UK

Session Introduction

12:45-13:10Title: MedDRA SMQs: Physician ratings of important terms for diagnosis of cardiac failure and acute pancreatitis- A Delphi study Michelle perry, Aspen Pharmacare Trading Limited, Ireland

Lunch Break 13:10-14:10Workshop

14:10-15:10Inefficiencies in pharmacovigilance: What we can do now and what could be done in the futureGiovanni Furlan, Helsinn Birex, Ireland

15:10-15:35Title: Over a century of Alzheimer and still no cause in sight: Is pharmacovigilance asleep on the job?G Robert Jones, Cancer Research Unit, UK

Networking & Refreshment Break 15:35-15:50Workshop

15:50-16:25The EU-RMP - Planning risk management in a feasible fashionAngela van der Salm, DADA Consultancy B.V, Netherlands

16:25-16:45Title: Extended EudraVigilance medicinal products dictionary (xevmpd)Alistair Coates, Oviya MedSafe, UK

Workshop

16:45-17:15Tomorrow, today: Systems approaches to enhance pharmacovigilance and risk managementGreg Koski, Alliance for Clinical Research Excellence and Safety, USA

Keynote Forum

Networking and Refreshment Break: 11:00-11:15

Scientific Program

09:55-10:00 Introduction10:00-10:30 Greg Koski Alliance for Clinical Research Excellence and Safety, USA10:30-11:00 Angela van der Salm DADA Consultancy B.V. Netherlands

11:15-11:45 Peter Lannon Lanpharm Consulting T/A Lanpharm Services, UK11:45-12:15 Kieran O’Donnell TMC Pharma Services, UK12:15-12:45 Alistair Coates Oviya MedSafe, UK

17:15-17:35Title: V is for Venn diagramsKriss Harris, Eisai, UK

17:35-18:00Title: Creating high quality statistical graphs for publicationsKriss Harris, Eisai, UK


Gates SuiteTrack 2: Pre-Clinical and Clinical Trials & Case ReportTrack 3: Clinical Trials on Drugs used in Various Disorders, Pharmacotherapy and PharmacotherapeuticsTrack 4: Adverse Drug Reactions Track 10: Good Pharmacovigilance Practice and Pharmacoepidemiology Session Chair: Subodh Bhardwaj, Arable Corporation, USASession Co-Chair: Pramod Wable, Daiichi Sankyo Development Ltd., UK

10:00-10:25Title: Combining quantitative and qualitative methods in signal detection and evaluation in pharmacovigilanceMichelle Perry, Aspen Pharmacare Trading Limited, Ireland

Workshop

10:25-11:25Title Vaccine vigilance- Towards strengthening pharmacovigilanceSubodh Bhardwaj, Arable Corporation, USA

Networking & Refreshment Break 11:25-11:40

11:40-12:05Title: Evaluation of the clinical indications, adverse drug reactions, and Finasteride use in patients with benign prostatic hyperplasia in PolandTomasz Zabkowski, Military Medical Institute, Poland

12:05-12:30Title: ADR is a threat more to children and women than adult maleSagar D Kadam, Babanrao Pachpute Vichardhara Trust's Group of Institutions, India

12:30-12:55Title: The regulation of allogeneic human cells and tissue products as biomaterialsKazuo Yano, Tokyo Women’s Medical University, Japan

Lunch Break 12:55-14:00

14:00-14:25Title: Pharmacovigilance: State of pharmacovigilance in developing countries: Lomie’s hospital (East Region / Cameroon) in regard to the harmonization of new European reglementations of pharmacovigilanceCarolle Laure Matene Kpoumie, ONMC, Paris

Workshop

14:25-15:25Title: Lean, six sigma and ISO and their applications in clinical trials/researchPramod Wable, Daiichi Sankyo Development Ltd, UK

15:25-15:50Title: Challenges and issues in pharmacovigilance of herbal medicines in IndiaMahek Arora, Amity University, India

Panel DiscussionsNetworking & Refreshment Break 15:50-16:05

16:05-17:05 Poster Presentations

PC 01Title: The influence of co-prescribed GABA-ergic drugs on anti-depressant compliance in patients with depression: A prospective study in a South African private healthcare cohortMartha Susanna Lubbe, North-West University (NWU), South Africa

PC 02Title: The importance of pharmacovigilance, now and in the futureMichelle perry, Aspen Pharmacare Trading Limited, Ireland

PC 03Title: Effect of Stachys mialhesi de noe on the inflammation induced by hyperhomocysteinemia in cardiovascular diseasesSakina Zerizer, University of Constantine, Algeria

PC 04Title: Uncommon serum creatine phosphokinase and lactic dehydrogenase increase during diosmin therapy: Two case reportsGiulia Milano, University of Genova, Italy

PC 05Title: An observational study of cutaneous adverse drug reactions in a teaching hospitalDeepti Chopra, Hamdard Institute of Medical Sciences and Research, India

PC 06Title: Attitude and awareness of adverse drug reaction reporting by health professionals in seven hospitals in the holy city of makkah, kingdom of Saudi ArabiaNaif Al Hazmi, Bradford University, KSA

PC 07Title: Pharmacokinetic-model based microfluidic multi-organ-on-a-chip for testing whole-body response to xenobiotic compoundsJong Hwan, Hongik University, South Korea

PC 08Title: Sakina Zerizer, University of Constantine, AlgeriaMartha Susanna Lubbe, North-West University (NWU), South Africa


Gates SuiteTrack 5: Pharmacokinetics and PharmacodynamicsTrack 6: Pharmacy Practices and its ChallengesTrack 12: Clinical Pharmacology and BiopharmaceuticsSession Chair: Subodh Bhardwaj, Arable Corporation, USASession Co-Chair: Doaa A Ghareeb, Alexandria University, Egypt

10:00-10:25Title: Medication administration errors in pediatric ward: An observational studyZayed Alsulami, Alkharj Military Industries Corporation Hospital, KSA

Workshop

10:25-11:25Title: Potential molecular mechanism of Berberise Vulgaris extract, berberine and berberine chitosan nanoparticles in Alzheimer treatmentDoaa A Ghareeb, Alexandria University, Egypt

Networking & Refreshment Break 11:25-11:40

11:40-12:05Title: Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands (OA treat): Study protocol for an on-going randomized controlled trialPascal Klaus, Charite - Universitatsmedizin Berlin, Germany

12:05-12:30Title: Rapid, accurate and simple microfluidic device based on fluorescent read-out immunoassay for the determination of oral anticoagulants compounds in treated patientsJ Pablo Salvador, CIBER-BBN, Spain

Lunch Break 12:30-13:30Award Ceremony

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**for available speaker slots** · title: pharmacovigilance: state of pharmacovigilance in...

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for available speaker slots · title: pharmacovigilance: state of pharmacovigilance in...